Opioid poisoning is a leading cause of preventable mortality in North America. Emergency departments are open 24/7 and frequently provide care to people who use illicit opioids. While emergency departments offer critical opportunities to reverse drug toxicity, mitigate harm, and initiate longer-term treatment, there is limited high-quality evidence to guide emergency care for people presenting with opioid poisoning and/or use disorder. Our objective is to establish a national registry of patients presenting to emergency departments with opioid poisoning and produce timely evidence to inform clinical care, public health surveillance and policy. We will use the Canadian Emergency Department Research Network (CEDRN) data sharing and membership agreements, infrastructure and expertise to create the CEDRN Opioid Registry to collect data on consecutive patients of all ages presenting to participating emergency departments with suspected opioid poisoning. A waiver of informed consent for registry inclusion will ensure absence of volunteer bias. We will automate screening and data extraction from electronic health records. We will capture data from emergency medical services, emergency departments, and in-hospital care, including demographics (e.g., age, sex at birth, housing), presentation characteristics (e.g., vital signs, chief complaint), investigations (e.g., urine toxicology), treatments (e.g., medications), harm-reduction interventions (e.g., take-home naloxone), and consultations (e.g., physician, social work, peer support). We will collect short-term outcomes (e.g., disposition) and link data with administrative sources to ascertain retention on opioid agonist therapy, revisits, admissions and mortality. We will verify data quality and validate definitions by comparing automatically extracted electronic health record data with manually extracted data. We will measure the inter-rater reliability of data elements and the diagnostic performance of discharge diagnoses. We anticipate using mixed-effects models with splines to examine associations between treatments and outcomes, and regression models, internal bootstrap validation, and nomograms to derive clinical decision rules to predict mortality. Our data can also be used for public health surveillance. The CEDRN Opioid Registry will capture harmonized clinical data describing emergency care for patients presenting with opioid poisoning and allow us to create real-world timely evidence to inform clinical care, public health surveillance and policy. NCT07466784 (20 February 2026).
Opioid agonist treatment (OAT) remains the standard of care for people with opioid use disorder in Canada and the United States. Despite rising rates of overdose among youth (aged 16–24), OAT continues to be underutilized in this population. To reduce these gaps, we gathered experts’ recommendations on the development and implementation of youth-centred models of care for OAT. This qualitative research study was conducted between March 2024 and March 2025 in British Columbia (BC, Canada), where overdose is one of the leading causes of accidental death among youth. The study involved semi-structured expert interviews, conducted with four participant groups with expertise on the development and implementation of OAT for youth, including youth (aged 16–24) with experience accessing OAT, caregivers of youth with such experience, service providers, and decision-makers. Participants were recruited purposefully through youth mental health and substance use services across BC. A directed content analysis was performed on transcribed interviews to synthesize and describe experts’ recommendations for improving the delivery of OAT to youth. A total of 17 experts participated, including n = 6 youth, n = 4 caregivers, n = 5 service providers, and n = 2 decision-makers. The analysis led to the identification of eight recommendations: (1) establishing and maintaining trusting relationships with youth; (2) regularly checking in with youth about their goals, benefits, and challenges with OAT; (3) presenting all medication options and their benefits and challenges; (4) collaboratively developing OAT induction plans; (5) delivering OAT as part of a comprehensive approach; (6) delivering OAT in low barrier and non-judgmental settings; (7) collaboratively developing tapering processes; and (8) empowering and supporting caregivers. Recommendations were grounded in four foundational pillars, which emphasized positive youth–service provider relationships, flexible treatment plans, and service delivery settings that are low-barrier and holistic. This study outlines experts’ recommendations for youth-centred models of care for OAT. Future research is needed to examine the implementation of youth-centred models of care for OAT, with specific attention to how these models address the diverse needs of youth across different communities, age ranges, genders, and clinical, social, and cultural contexts.
Polysubstance use, the predominant pattern of substance use among individuals with moderate to severe substance use disorder (SUD), confers increased mortality and morbidity risk and worsens clinical treatment outcomes. Despite evidence-based treatment for individual SUDs, including medications for opioid use disorder (OUD) and alcohol use disorder (AUD), and contingency management for stimulant use disorder (StUD), treatment trials rarely address multiple substances. A minority of individuals with active polysubstance use disorder (PSUD) seek specialty addiction treatment but do frequent primary care. The CoCare trial will study the efficacy of a collaborative care intervention to decrease polysubstance use among adult primary care patients with moderate to severe PSUD. The CoCare trial is a cluster-randomized controlled trial, randomized at the level of the PCP, conducted in 6 distinct geographic sites. CoCare tests the efficacy of the CoCare intervention in comparison to enhanced usual care in adult primary care patients with moderate to severe opioid, stimulant and/or alcohol SUD, with concurrent use of at least two of these substance classes. The 6 month Co-Care intervention includes: (1) a practice-embedded nurse care manager (NCM) who manages medications for OUD and AUD, conducts contingency management, links to mental health and addiction treatment, and provides general care management; (2) the patient’s PCP who prescribes medications and manages medical conditions; (3) a remote Health coach who provides patient-centered counseling, motivational enhancement, and cognitive behavioral therapies; and (4) an addiction specialist who advises the NCM and Health Coach on evidence-based patient care using population health management tools. The primary outcome is self-reported days of opioid, stimulant, and heavy alcohol (women 4 + drinks/day, men 5 + drinks/day) use summed over months 4–6. assessed monthly via text messages using items from the Addiction Severity Index. Secondary outcomes include progress in treatment and recovery, substance use frequency and severity, mental health, quality of life, healthcare utilization, overdose risk, pain, and PCP attitudes and behaviors. Analysis of the primary outcome data is based on a mixed-effects negative binomial model with a log link. Giving the importance of addressing polysubstance use disorder in primary care settings, this trial of collaborative care offers a blueprint for a feasible and effective approach. Clinicaltrials.gov, identifier NCT06116266, October 31, 2023.
Alcohol use disorder (AUD) is associated with poorer health outcomes among people with HIV (PWH) including serious interactions with medications. However, we lack treatments that address AUD in the context of HIV and polypharmacy. We describe the protocol for three open-label pilot studies to determine the feasibility, acceptability, safety, tolerability, and potential changes in alcohol consumption associated with the off-label use of medications with potential efficacy for the treatment of AUD – spironolactone, varenicline, and semaglutide – among PWH with AUD and polypharmacy. We hypothesize that off-label use of each of these three medications with a Clinical Pharmacist-delivered behavioral intervention will be feasible, acceptable, safe, tolerable and demonstrate changes in alcohol consumption. Conducted as part of the HIV and Alcohol Research Center focused on Polypharmacy (HARP) activities, we aim to enroll 60 adults (20 participants per pilot study) with AUD, phosphatidylethanol (PEth) levels > 20 mg/nL, and with polypharmacy (> 5 medications) receiving care at the Atlanta Veterans Affairs Infectious Disease Clinic. Participants will be prescribed the study medication for 12 weeks by an Addiction Physician and will meet with a Clinical Pharmacist to receive a motivational interviewing-based counseling session regarding their personal health risks related to alcohol use in the context of polypharmacy. Feasibility will be assessed by study recruitment, enrollment, and retention, as well as visit attendance and study medication adherence, with the primary outcome being the proportion of patients offered participation who completed enrollment. Acceptability will be assessed through a participant satisfaction questionnaire as well as analyses of qualitative data collected from a subset of participants regarding different components of the intervention and their impact on alcohol consumption. Safety and tolerability will be assessed through review of clinical and laboratory data as well as frequency of adverse events. Descriptive data will compare pre- and post-intervention readiness to change metrics, self-reported and laboratory-based measures of alcohol consumption including PEth, levels of polypharmacy, self-reported and laboratory-based measures of tobacco use, bothersome symptoms, and biomarkers of health related to HIV. Interventions that address AUD in the context of polypharmacy among PWH are needed. Future research will focus on further evaluating the most promising of these pilot studies through randomized controlled trials to evaluate the efficacy of these novel intervention packages. NCT06004830, Date of Registration: August 16, 2023.
Engagement in methadone treatment for opioid use disorder (OUD) remains a major challenge. Many patients drop out of treatment prematurely, thus contributing to opioid-related disparities in the United States. Communities like Baltimore City, Maryland are particularly burdened by the opioid crisis, and many residents experience various stressors that may be barriers to treatment engagement. Previous reports have identified neighborhood stressors, such as residential instability, financial difficulties, and other individual and community factors as significant predictors of methadone treatment engagement that disrupt recovery progress. This study sought to understand how patients with OUD in a low-income urban neighborhood in Baltimore City perceive their neighborhoods and how stressful neighborhood factors shape their engagement with methadone treatment. Semi-structured, in-depth interviews were conducted with 18 adults from the HEAL Together trial that took place in a Baltimore City methadone clinic. The interview guide examined how neighborhood stressors, such as built environment features, finances, housing stability, and transportation, influence methadone treatment outcomes and recovery experiences. Transcripts were analyzed using inductive and deductive thematic analysis. A codebook was developed, and main- and sub-themes were derived from the coded data. We found that individual- and community-level neighborhood stressors were identified as barriers to consistent methadone treatment engagement and attendance. Economic stressors, specifically financial difficulties, and pervasive drug exposure, emerged as prominent triggers that disrupted engagement. Despite these barriers, many participants reported developing personal strategies to avoid high-risk situations and expressed strong motivation to remain engaged in treatment. Neighborhood stressors, especially financial instability and drug exposure, pose substantial challenges to methadone treatment engagement. Yet, participants demonstrated coping strategies and motivation to sustain care. These findings reveal the role of the neighborhood as a source of risk and opportunities for resilience. Addressing the economic and community barriers while reinforcing patient-driven coping and support mechanisms may enhance methadone treatment engagement and inform community-level interventions to reduce opioid-related disparities in urban communities.
